
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78166-78167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26758]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0086]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Potential Tobacco Product Violations Reporting Form

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
contained in FDA's Tobacco Product Violations Reporting Form.

DATES: Submit either electronic or written comments on the collection 
of information by January 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0086 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Potential Tobacco Product 
Violations Reporting Form.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party.

[[Page 78167]]

Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Potential Tobacco Product Violations Reporting Form--OMB Control Number 
0910-0716--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended section 201 et seq. 
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
321 et seq.) by adding a new chapter granting FDA important new 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors. FDA is requesting an extension of OMB approval 
for the collection of information to accept consumer and other 
stakeholder feedback and notification of potential violations of the 
FD&C Act, as amended by the Tobacco Control Act.
    FDA created a Tobacco Call Center (with a toll-free number: 1-877-
CTP-1373). Callers are able to report potential violations of the 
Tobacco Control Act, and FDA may conduct followup investigations based 
on information received. When callers report a violation, the caller 
will be asked to provide as much certain information as they can 
recall, including: The date the potential violation occurred; product 
type (e.g., cigarette, smokeless, roll-your-own, cigar, e-cigarette, 
hookah, pipe tobacco); tobacco brand; potential violation type; type of 
potentially violative promotional materials; who potentially violated; 
and the name, address, phone number, and email address of the potential 
violator. The caller will also be asked to list the potential 
violator's Web site (if available), describe the potential violation, 
and provide any additional files or information pertinent to the 
potential violation.
    FDA currently provides a form that may be used to solicit this 
information from the caller (Form FDA 3779, Potential Tobacco Product 
Violations Report), and seeks renewal of Form FDA 3779. This form is 
posted on FDA's Web site. The public and interested stakeholders are 
also able to report information regarding possible violations of the 
Tobacco Control Act through the following methods: Calling the Tobacco 
Call Center using the Center for Tobacco Products' (CTP) toll-free 
number; using a fillable Form FDA 3779 found on FDA's Web site; 
downloading a PDF version of the form to send via email or mail to FDA; 
requesting a copy of Form FDA 3779 by contacting CTP and sending by 
mail to FDA; and sending a letter to FDA's CTP.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
         Activity and FDA form 3779              Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Reporting violations of the FD&C Act, as                 750               2           1,500  0.25 (15 minutes).........................             375
 amended by the Tobacco Control Act via
 telephone, Internet form, mail, smartphone
 application, or email.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that submitting the information (by telephone, 
Internet form, paper form by mail, or email) will take 0.25 hour (i.e., 
15 minutes) per response. Based on the type and rate of reporting that 
has been submitted through the Potential Tobacco Violation Reporting 
Form in the past, in addition to the increase that FDA has recently 
experienced in the rate of reporting due to the recent rule, ``Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic 
Act, as Amended by the Family Smoking Prevention and Tobacco Control 
Act,'' FDA estimates the number of annual respondents to this 
collection of information will be 750, who will each submit 2 reports 
by telephone, Internet form, paper form, or email. Each report is 
expected to take 0.25 hour to complete and submit; therefore, total 
burden hours for this collection of information is estimated to be 375 
hours (1,500 responses x 0.25 hour per response).

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26758 Filed 11-4-16; 8:45 am]
 BILLING CODE 4164-01-P


